BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1935752 · Received December 16, 2010

    Report

    Report Number
    2183996-2010-02635
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED ONE OF HIS INFUSION SETS BROKE BECAUSE HE DIDN'T KNOW HOW TO USE IT. PT STATED THE SECOND ONE ATTACHED FINE AFTER HE READ THE DIRECTIONS. PT REPORTED THIS EVENING HE DETACHED FROM THE INFUSION HEADSET SO HE COULD TAKE A SHOWER AND WHEN HE WENT TO RECONNECT TO THE INFUSION DEVICE A LITTLE WHILE LATER, THE PART OF THE INFUSION HEADSET THAT CONNECTS TO THE INFUSION TUBING HAD "SNAPPED OFF" AND WAS NOWHERE TO BE FOUND. PT STATED HE DID NOT RECALL BUMPING INTO ANYTHING OR CAUSING THAT PART TO BREAK OFF. PT WAS NOT AT HOME AND IS NOT SURE IF HE WILL HAVE ENOUGH PRIVACY TO CHANGE HIS INFUSION SITE. PT REPORTED HE DOES HAVE AN ADDITIONAL INFUSION SET WITH HIM. ADVISED PT TO CHANGE HIS INFUSION SITE AS SOON AS POSSIBLE SINCE THE INFUSION TUBING HAS NOTHING TO CONNECT WITH AND HE IS NOT RECEIVING ANY INSULIN. REVIEWED BASIC USE OF THE INFUSION SET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INSULIN| INSULIN INFUSION SET